Transcatheter Device Safe, Effective in Complex Internal Carotid Aneurysms

 Download this article's Factoid (PDF & PPT for Gold Subscribers

Large and giant aneurysms of the internal carotid artery can be safely and effectively treated with an endoluminal device that results in a high rate of complete occlusion and a reasonably low rate of adverse neurologic events, according to a multicenter study in the June 2013 issue of Radiology.

Researchers led by Tibor Becske, MD, of New York University Langone Medical Center (New York, NY), studied 108 patients with recent, unruptured large and giant wide-necked internal carotid aneurysms enrolled in the pivotal PUFS (Pipeline for Uncoilable or Failed Aneurysms) trial. All patients were treated with the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, CA) at 1 of 10 centers in the United States, Turkey, and Hungary from November 2008 to July 2009.

The PED, approved by the US Food and Drug Administration in 2011, features flexible, low-porosity endoluminal sleeves that enable direct reconstruction of the affected parent artery and also reduce hemodynamic exchange between the aneurysm and parent artery.

High Procedural Success, Low Adverse Events

Procedural success was 99.1%. The vast majority of patients (98%) received more than 1 PED. The median number of implanted PEDs was 3 (range, 1-15) per target aneurysm. Procedure time averaged 124 minutes, and fluoroscopy time averaged 48 minutes.

Of 106 aneurysms in 104 patients, 73.6% met the combined primary effectiveness endpoint of complete occlusion at 180 days without major stenosis or use of adjunctive coils (95% posterior probability interval 64.4-81.0%; P < 0.001 vs. fixed rate of 50%). Reasons for failing to meet the primary effectiveness endpoint were:

• Residual neck (7.5%)
• Residual aneurysm filling (5.7%)
• Death (2.8%)
• Carotid occlusion (2.8%)
• Withdrawal from study (1.8%)
• Refusal of angiogram (1.8%)
• Parent artery stenosis > 50% (1.8%)
• Use of adjunctive coils in aneurysm fundus (0.9%)
• Carotid-cavernous fistula (0.9%)

At 1-year follow-up, the rate of complete aneurysm occlusion on angiography was 86.8%.

Major ipsilateral stroke or neurologic death at 180 days, the primary safety endpoint, occurred in 5.6%. The most frequent serious adverse events were:

• Amaurosis fugax (4.7%)
• Headache (4.7%)
• Intracranial hemorrhage (4.7%)
• Non-neurologic bleeding (4%)
• Ischemic stroke (3.7%)
• Cardiac arrhythmia (2.8%)

Higher Occlusion Rate vs. Other Therapies

“Taken together, the data indicated that the PED is safe and effective for the target population of large and giant wide-necked internal carotid artery aneurysms,” the study authors write.

According to the paper, the device’s safety and efficacy compare favorably with those of prior studies that used reconstructive coil-endosaccular treatment. Additionally, the rates of complete aneurysm occlusion “are substantially higher with the PED than those that were observed after coiling, with or without the adjunctive use of higher porosity stents,” Dr. Becske and colleagues report.

The researchers also point out that compared with deconstructive therapies, the PED offers the advantage of parent artery preservation, which may be particularly important for patients lacking adequate collateral support who would require a surgical bypass prior to parent vessel sacrifice.

However, they acknowledge that since the study lacked a control group, it is impossible to directly compare the novel device with other aneurysm therapies. In addition, the aneurysms represent a limited anatomic distribution, making it difficult to generalize the findings to all cerebral aneurysms.

Study Details

Mean patient age was 57 years, and 88.9% were women. Mean aneurysm size was 18.2 mm, with 20.4% measuring larger than 25 mm in maximum dimension. Most involved the cavernous or paraophthalmic segments of the internal carotid artery.

 

---

Source:
Becske T, Kallmes DF, Saatci I, et al. Pipeline for uncoilable or failed aneurysms: Results from a multicenter clinical trial. Radiology. 2013;267:858-868.

 

 

Related Stories:

• Registry Study Defines Proper Role for Embolization Device for Intracranial Aneurysm
• Changes in Treatment Fail to Budge Outcomes for Unruptured Intracranial Aneurysms
• Endovascular Treatment Feasible for Unruptured Intracranial Aneurysms